Source: FDA, National Drug Code (US) Revision Year: 2018
VARIZIG [Varicella Zoster Immune Globulin (Human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals.
High risk groups include:
VARIZIG administration is intended to reduce the severity of varicella. Administer VARIZIG as soon as possible following varicella zoster virus (VZV) exposure, ideally within 96 hours for greatest effectiveness.
For intramuscular use only.
Each vial of VARIZIG contains a minimum potency of 125 IU in 1.2 mL.
Bring VARIZIG to room temperature prior to use.
Inspect VARIZIG for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates.
VARIZIG is for single use only. Discard any unused portion.
Dosing of VARIZIG is based on body weight. Administer a single dose of VARIZIG intramuscularly as recommended in Table 1.
The minimum dose is 62.5 International Units (IU) for small infants under two kilograms body weight; the maximum dose of 625 IU should be administered for all patients greater than 40 kilograms in weight.
Table 1. VARIZIG Dose and Volume of Administration:
| Weight of Patient | VARIZIG Dose | Volume to Administer* (milliliters) | ||
|---|---|---|---|---|
| Kilograms | Pounds | IU | Number of Vials | |
| ≤2.0 | ≤4.4 | 62.5 | 0.5 | 0.6 |
| 2.1–10.0 | 4.5–22.0 | 125 | 1 | 1.2 |
| 10.1–20.0 | 22.1–44.0 | 250 | 2 | 2.4 |
| 20.1–30.0 | 44.1–66.0 | 375 | 3 | 3.6 |
| 30.1–40.0 | 66.1–88.0 | 500 | 4 | 4.8 |
| ≥40.1 | ≥88.1 | 625 | 5 | 6.0 |
* Extractable volumes are confirmed using a 21 gauge needle as per USP General Chapters <1> Injections.
Consider a second full dose of VARIZIG for high risk patients who have additional exposures to varicella greater than three weeks after initial VARIZIG administration.
For intramuscular use only.
Divide the intramuscular dose and administer in two or more injection sites, depending on patient size. Do not exceed 3 milliliters per injection site.
Inject into the deltoid muscle or the anterolateral aspects of the upper thigh. Due to the risk of sciatic nerve injury, do not use the gluteal region as a routine injection site. If the gluteal region is used, only use the upper, outer quadrant.
To prevent the transmission of infectious agents from one person to another, use a new disposable sterile syringe and needle for each individual patient.
Manifestations of an overdose of VARIZIG administered intramuscularly are expected to be pain and tenderness at the injection site.
Store VARIZIG at 2 to 8°C (36 to 46°F). Do not freeze. Do not use after expiration date.
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